Comprehensive study of co-processed excipients F- Melts®: Flow, viscoelastic and compacts properties

This article aims to compare three commercially available co-processed excipients (CPEs), namely the F-Melts® type C,M and F1. All three CPEs were subjected to the evaluation of their physical properties and afterwards compacts were prepared using three compression pressures. The viscoelastic properties and ejection force were assayed during the compression and the compacts were evaluated in compliance with the European Pharmacopoeia and subjected to other relevant testing (AFM imaging, wettability etc.).

Based on the obtained results it could be stated that the C and M have very similar properties according to their similar composition. In general, it is difficult to select the best CPE as they possess different properties fitting the versatile needs of manufacturers. However, the obtained results revealed that the M and F1 are more suitable for the incorporation of moisture sensitive ingredients than the C.

Introduction:

Orally dispersible tablets (ODTs) rapidly disintegrate after their administration to the oral cavity forming an easily swallowable dispersion that is advantageous for patients with swallowing difficulties (children, seniors, psychiatric and dysphagia patients). As ODTs are liquefied in mouth, they combine the benefits of liquid and conventional solid dosage forms, such as good stability, easy dosing, and swallowing connected with high bioavailability of the administered drug. One of the widely used methods for the production of ODTs is the direct compression (DC) [1,2]. The principle lies simply in weighing, blending and compressing the appropriate components. Thus gaining the advantages of a limited number of manufacturing steps, reduced time of manufacturing and lower energy demands. This results in cost reduction, lower variability of the production, an improved stability of the active substance (API), shorter disintegration and dissolution of manufactured tablets, easier validation of the production and a lower risk of microbial contamination [3]. On the other hand, by omitting the granulation process, manufacturing of tablets with a high content of active ingredients (API) is limited, as particles of API often segregate during blending, which may negatively influence the content uniformity.Moreover, due to a powder blend usually having worse flow properties, the weight variability may also increase [4]. Furthermore, the higher surface area of the powder blend requires the addition of a larger amount of the lubricant. The tablets may also have lowermechanical resistance,which can be observed during the stress testing [5]. To address these limitations and disadvantages, producers decided to refine direct compression excipients. Firstly, mono-excipients with improved flow properties and compressibility were introduced. Secondly, co-processed excipients (CPEs) were put in practice. CPEs are blends containing mostly fillers, binders, and disintegrants and sometimes also surfactants or lubricants. These blends are processed by various technologies, such asmelt granulation, dry granulation, wet granulation, fluid bed granulation and cocrystallisation, but mainly spray drying (SpD) [6]. The SpD leads to the formation of highly porous particles with good flowability and tabletability, while ensuring short-time disintegration in the physiological fluids, particularly in saliva. Usually the spherical shape of the newly formed particles improves the flow properties and provides a better rearrangement of the particles in the die during tableting, resulting in better compaction characteristics [7]. However, although the composition of these CPEs may be virtually similar, the small changes in the components’ characteristics can make them behave differently after compression [8]. Click here to download the whole article as a PDF

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F-MELT® F1
F-MELT® C
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